Oxycodone Hydrochloride

Product NDC
52959-131
11-digit product format
529590131
Labeler code
52959
Product ID
52959-131_85ad079e-088c-493d-bd2a-deaa107391bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA077712
Marketing category
ANDA
Marketing start
2009-03-02
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct52959-131IInactivated by FDA2026-08-03
excluded packagepackage52959-13152959-131-02IInactivated by FDA2026-08-03
excluded packagepackage52959-13152959-131-30IInactivated by FDA2026-08-03
excluded packagepackage52959-13152959-131-50IInactivated by FDA2026-08-03
excluded packagepackage52959-13152959-131-60IInactivated by FDA2026-08-03
excluded packagepackage52959-13152959-131-90IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077712-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-31
A077712-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-31
A077712-003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-02
A077712-004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-13
A077712-005OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A077712-001AB
A077712-002AB
A077712-003AB
A077712-004AB
A077712-005AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-135bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 55 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077712-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077712-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077712-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077712-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077712-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077712-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077712-005AB15bbf6a4d5a75…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEStrides Pharma Science Limitedf3116ebf-d72c-4e98-aa50-006be4770c862026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEAsclemed USA, Inc.056bdaac-4a43-42f0-9435-f349d3ccc1282025-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDERedpharm Drug439c2de6-3ea5-e829-e063-6294a90aa77d2025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack08977126-9671-4d87-9724-1599ca86e1812025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY3ca9f0d9-a40d-4416-e063-6394a90aec8b2025-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HCLOXYCODONE HCLDirect_Rx3245cd2f-8ad0-b755-e063-6394a90a603c2025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HCLOXYCODONE HCLDirect_Rx3a849aeb-b72c-5cde-e063-6394a90a97682025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HCLOXYCODONE HCLDirect_Rx32323565-5add-96a9-e063-6294a90a5b4e2025-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HCLOXYCODONE HCLDirect_Rx323148b2-809a-db11-e063-6294a90abe362025-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
b8cd3792-f010-440e-ac63-7713119fde04Product name920220110
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3Product name920190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
b7a189a6-82e9-f884-a16b-8cdc7e7d1556Product name620170913
5da64f4c-1e90-423d-af7a-5a52bb3e823eProduct name420170726
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6Product name120170628
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778Product name120161103
68d3ff71-7803-4cf4-ba84-71ce4712df22Product name120160620
07e5b999-fda7-79c9-8f77-8380537ade79Product name420160517
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7fa873c5-fb27-7119-0a05-634ad477dea7Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
f46484d2-0de6-24f4-bf73-a8f2af6723efProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-131-02Oxycodone Hydrochloride120 in 1 BOTTLE, PLASTICTABLET1202
52959-131-30Oxycodone Hydrochloride30 in 1 BOTTLE, PLASTICTABLET302
52959-131-50Oxycodone Hydrochloride50 in 1 BOTTLE, PLASTICTABLET502
52959-131-60Oxycodone Hydrochloride60 in 1 BOTTLE, PLASTICTABLET602
52959-131-90Oxycodone Hydrochloride90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-131-02EA - Each52959-131418a7d2d-4c4d-48ed-bf0a-d6acc38a7ef412012-07-24
52959-131-30EA - Each52959-131ae6c5337-4340-4313-9efb-159a7da1969012012-07-24
52959-131-50EA - Each52959-1312825064a-66bc-4bb0-ad33-7ef31fd47e1212012-07-24
52959-131-60EA - Each52959-131590a05fb-5f12-40b1-87a3-0ce22f9033bf12012-07-24
52959-131-90EA - Each52959-13140d22b88-5200-470f-bc3e-e331554fd00a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-131OXYCODONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 5 package rows20111216_3efb2cf8-9b0e-4d76-afb1-c4ecd514d534.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049611oxyCODONE HCl 15 MG Oral TabletPSN3efb2cf8-9b0e-4d76-afb1-c4ecd514d5342
1049621oxyCODONE HCl 5 MG Oral TabletPSN3efb2cf8-9b0e-4d76-afb1-c4ecd514d5342
1049611oxycodone hydrochloride 15 MG Oral TabletSCD3efb2cf8-9b0e-4d76-afb1-c4ecd514d5342
1049621oxycodone hydrochloride 5 MG Oral TabletSCD3efb2cf8-9b0e-4d76-afb1-c4ecd514d5342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-131-0252959013102120 in 1 BOTTLE, PLASTICHistorical
52959-131-305295901313030 in 1 BOTTLE, PLASTICHistorical
52959-131-505295901315050 in 1 BOTTLE, PLASTICHistorical
52959-131-605295901316060 in 1 BOTTLE, PLASTICHistorical
52959-131-905295901319090 in 1 BOTTLE, PLASTICHistorical